BACKGROUND OF THE INVENTIONThe present invention generally relates to apparatus and methods for extending a spine reconstruction rod and, more specifically, to an apparatus and method for providing a strong, durable inline extension of a spine reconstruction rod.
Referring toFIG. 1, modern reconstructive spine surgery often involves aconstruct10 of pedicle screws12 (only one is shown in the Figure) and arod14.FIG. 1 shows alast pedicle screw12 at anend16 of therod14. One of the major problems with theseconstructs10 is that patients will often develop adjacent level disease. It is currently unknown if adjacent level disease is caused by the surgical construct or the result of natural progression of the original condition. It may be a combination of the two causes.
Either way, the adjacent level disease will often make it necessary for the patient to come back later and extend the original construct (e.g., construct10) up or down the spine. A problem with this extension procedure is how to lengthen the rod to incorporate the new spine levels in the construct. Current methods consist of a “domino” type linkage between the old and new rods.
There are two styles of “domino” linkages. One style is side by side; the other is inline. Both styles are essentially solid blocks of metal. In the side by side, the domino clamps the new rod along the side of the old rod. For the inline configuration, one end of the old rod is slid into the domino while the new rod is slid into the other end of the domino.
A problem with the inline design is that there is not enough space to put the rod of the original construct and the rod of the new construct end to end without having an extended length of spine reconstruction rod (including the length of the domino) that is not attached to the spine with a pedicle screw. In other words, the location where a pedicle screw of the new construct would typically be attached to the spine has to be changed to a location further down (relative to the joint between the new rod and the old rod) the spine due to the domino occupying the space where the first pedicle screw of the new construct would otherwise be located.
Another problem with the inline design is that often there is not enough of alength16aof rod left on the original construct past thelast pedicle screw26 at theend16 ofrod14 to insert into the domino.
A problem with the side by side domino design is one of space. The new rod, being placed along side of the original rod, is no longer inline with the original rod. Typically, a rod extension should be inline with the original rod. Therefore, significant bending of the new rod is necessary to bring the new rod back inline with the original rod. This offset and bending makes the final construct weaker than if a single, longer rod were installed according to prior art methods. Such an installation of a single, longer rod, however, as discussed below, requires exposing the entire original rod for its removal. Furthermore, the additional bulk of the side by side construct is also a problem (especially in young, thin children with scoliosis).
Another conventional way to address adjacent level disease is to completely expose the original construct (often involving a very large incision when only a single level needs to be added), remove the old rod, and replace it with a longer rod to immobilize both the original and the new spine reconstruction regions.
As can be seen, there is a need for an apparatus and method for extending a reconstruction rod which does not involve skipping a pedicle screw in the new construct, exposing the entire old construct, or adding a significant amount of size to the junction between the old and new construct.
SUMMARY OF THE INVENTIONIn one aspect of the present invention, a rod extender for extending an original rod comprises a rod extension base; and at least one arm attached to the rod extension base, wherein the at least one arm extends over an end of the original rod.
In another aspect of the present invention, a spine reconstruction rod extender for extending an original rod comprises a rod extension base; and a first arm and a second arm attached to and extending from the rod extension base, wherein the first arm fits into a rod receiving portion of a last pedicle screw of the original rod; and the second arm fits over the original rod to receive force from a set screw of the last pedicle screw.
In a further aspect of the present invention, a spine reconstruction rod extender for extending an original rod comprises a rod extension base; and a first arm having a minimum diameter smaller than a diameter of the original rod, the first arm fitting over the original rod to provide an inline extension of the original rod.
In yet a further aspect of the present invention, a method for extending a previously implanted spine reconstruction rod comprises exposing only an end of the previously implanted spine reconstruction rod, including a last pedicle screw thereof; positioning a rod extension in-line with the previously implanted spine reconstruction rod; and securing the rod extension to the previously implanted spine reconstruction rod.
In still another aspect of the present invention a method for extending a previously implanted spine reconstruction rod comprises inserting a rod extension device onto the previously implanted reconstruction rod; using an existing pedicle screw associated with the previously implanted spine reconstruction rod to secure the rod extension in-line to the previously implanted spine reconstruction rod; and omitting a connecting component not already associated with the previously implanted spine reconstruction rod to secure the rod extension to the previously implanted spine reconstruction rod.
These and other features, aspects and advantages of the present invention will become better understood with reference to the following drawings, description and claims.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is a perspective view of a pedicle screw and rod according to the prior art;
FIG. 2 is a perspective view of a rod extension according to the present invention;
FIG. 3 is a perspective view of the rod extension ofFIG. 2 being joined to an existing rod, according to the present invention;
FIGS. 4A through 4E are perspective views showing a method of attaching the rod ofFIG. 2, according to the present invention;
FIG. 5 is a close up view of a rod having a sharp end according to the present invention;
FIG. 6 is a perspective view of a clamp used to affix an existing rod to the rod of the present invention;
FIG. 7 is a partial cut away plan view of a rod used to change rod diameter of a construct, according to the present invention;
FIG. 8 is a perspective view showing a change in rod diameter with a clamp, according to the present invention;
FIG. 9 is a perspective view showing a rod extension device according to the present invention;
FIG. 10 is a perspective view showing a rod extension device without a pedicle screw cover according to the present invention;
FIG. 11 is a plan view of the rod extension device ofFIG. 9 installed on an original rod;
FIG. 12 is an end view of the rod extension device ofFIG. 9;
FIG. 13A is a bottom perspective view of the rod extension device ofFIG. 9, showing the last pedicle screw of the original rod;
FIG. 13B is a top perspective view of the rod extension device ofFIG. 9, showing the last pedicle screw of the original rod;
FIGS. 14A through 14C show steps for applying a clamp to the rod extension device ofFIG. 12; and
FIG. 15 is a flow chart describing a method of the present invention.
DETAILED DESCRIPTION OF THE INVENTIONThe following detailed description is of the best currently contemplated modes of carrying out the invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims.
Broadly, the present invention provides an apparatus and method for extending a reconstruction rod. Embodiments of the rod extender of the present invention, unlike conventional rod extenders discussed above, may not involve skipping a pedicle screw in the new construct, exposing the entire old construct, or adding the bulk of a domino to the junction between the old and new construct.
The present invention may result in an extension of an original rod into a new construct. The present invention requires exposing only the last pedicle screw of the old construct in order to extend the original rod. Moreover, the present invention may be useful when the new construct involves a different diameter rod as compared to the old construct. This occurs, for example, when a thoracic fusion needs to be extended into the neck.
As used herein, the term “construct” refers to a rod and screw assembly, for example, a spine reconstruction rod and pedicle screw assembly. An “old construct” or “original construct” refers to a rod and pedicle screw assembly previously implanted in a patient. A “new construct” refers to a rod and pedicle screw assembly to be implanted in a patient, for example, a “new construct” could refer to an original new implant or to an extension for an old construct.
As used herein, the term “last”, when referring to a “last pedicle screw” in an original construct, refers to the pedicle screw in the original construct which is located immediately adjacent to (without a pedicle screw therebetween) one end of the original rod. Typically, the “last pedicle screw” of the original construct refers to the pedicle screw at an end of the original rod from which an extension of that original rod is desired.
As used herein, the term “first”, when referring to a “first pedicle screw” in a new construct, refers to the pedicle screw in the new construct which is located immediately adjacent to (without another pedicle screw therebetween) one end of the new construct, this end being the end of the new construct adjacent to the end of the original construct being extended.
Referring toFIG. 2, there is shown a perspective view of anexemplary construct20 according to the present invention. Theconstruct20 may include arod extension22 which may fit onto anoriginal rod24 near the location of thelast pedicle screw26 of theoriginal rod24. The assembly of the construct will be discussed with reference toFIGS. 4A through 4C.
Referring toFIG. 3, there is shown a perspective view of therod extension22 ofFIG. 2 being inserted over the original rod24 (shown by dashed lines), according to the present invention. Therod extension22 may includearms30 projecting from arod extension body32. Therod extension22 may include ahollow sleeve portion34 at anend36 of therod extension body32. Thehollow sleeve portion34 may receive theoriginal rod24 as shown inFIG. 3. When fully in place, theoriginal rod24 may come close to (for example, within about 1-4 mm) or may abut against theend36 of therod extension body32. With therod extension body32 being close to theoriginal rod24, the location where the first pedicle screw (not shown) attaches to therod extension body32 of therod extension22 is not blocked, as may be the case with conventional rod extensions which use dominos that extend beyond the location where the first pedicle screw would attach to conventional rod extensions.
Thesleeve portion34 may be anysuitable length34afor providing support for theoriginal rod24 therewithin, and typically will be from about 6 to about 20 mm in length. Thearms30 also may be of anysuitable length30cfor providing attachment of therod extension22 tooriginal rod24, and typically will be from about 1 to about 1.5 cm in length.
Therod extension body32 may have adiameter32asimilar to those rods typically used in the past for spine reconstruction. For example, the present invention may includerod extension bodies32 having diameters of 6.35 mm, 5.5 mm, 3.5 mm and the like. Furthermore, therod extension22 of the present invention may be used with any type oforiginal rod24, including both rigid rods and flexible rods.
Referring toFIGS. 4A through 4E, there are shown, graphically, steps for extending theoriginal rod24 with arod extension22. InFIG. 4A, aset screw40 may be loosened or removed from thelast pedicle screw26 at anend42 of theoriginal rod24. Therod extension22 of the present invention may require the surgical exposure of only theend42 and thelast pedicle screw26 of theoriginal rod24.
InFIG. 4B, a dottedline50 shows an outer circumference of theoriginal rod24 when inserted in between thearms30a,30b. The diameter (not specifically shown) of thesleeve portion34 may be larger than the original rod24 (not shown), as thesleeve portion34 may not need to fit into therod receiving portion26aof thepedicle screw26. Therod extension body32 may have adiameter32adepending upon the particular application. For example, therod extension body32 may have a diameter that is the same as theoriginal rod24, that is larger than theoriginal rod24, or that is smaller than theoriginal rod24. Selection of the appropriate sizedrod extension body32 may be recognized as within the ability of one skilled in the spine reconstruction arts.
InFIG. 4C, thearms30a,30bof therod extension22 may slide over theend42 of theoriginal rod24. Onearm30amay be aligned to contact theset screw40 when theset screw40 is replaced onto thepedicle screw26. Theother arm30bmay be aligned to meet abottom portion44 of thepedicle screw26 as shown inFIG. 4C.
Typically, arod receiving portion26aof the pedicle screw26 (seeFIG. 4A) haswidth26bsized to match thediameter24aof theoriginal rod24. For this reason, thearms30a,30bof therod extension22 may fit into therod receiving portion26awhen aligned as described above (i.e., with the arms being at thebottom portion44 of thepedicle screw26 and at the top of therod receiving portion26a). This configuration may allow thearms30a,30bto fit into therod receiving portion26aof thepedicle screw26 without requiring changing thepedicle screw26 or resizing therod receiving portion26a.
FIGS. 4A through 4C show the arms having curvature similar to that of theoriginal rod24. Such curvature is useful, especially for thelower arm30b, so that thelower arm30bmay fit into thebottom portion44 of thepedicle screw26 in a manner similar to that of theoriginal rod24. Theupper arm30a, however, may be shaped similar to that of theoriginal rod24 or, alternatively, may have a flattenedtop portion46, as shown inFIG. 4D, which is a cross-sectional view of therod extension22 alongline4D-4D ofFIG. 4C. The flattenedtop portion46 may be useful to provide a flat surface to contact a bottom of theset screw40 when theset screw40 is reassembled into thepedicle screw26.
InFIG. 4E, the reassembly of theset screw40 into thepedicle screw26 with therod extension22 in place is shown. As discussed above, theoriginal rod24 may slide into thearms30a,30bof therod extension22 and fit into thesleeve portion34 of therod extension22 as shown inFIG. 4E. Once installed, therod extension22 may be secured to the spine by one or more new pedicle screws in a manner similar to conventional rods (see, for example,FIG. 1).
Referring now toFIG. 5, there is shown an exemplary configuration of theends60a,60bof thearms30a,30bof therod extension22. In this embodiment, thearms30a,30bmay be optionally “sharp”, as shown inFIG. 6, so as to assist in sliding thearms30a,30bover theoriginal rod24. “Sharp” ends60a,60b, as the term is used here, may result in leadingedges62a,62bof theends60a,60bof thearms30a,30bto have a thickness (not shown) smaller than the thickness of the remaining portions of thearms30a,30b.
Referring toFIG. 6, there is shown therod extension22 of the present invention attached to theoriginal rod24 in an alternate configuration as described below. Aclamp70 may be used to affix therod extension22 to theoriginal rod24 according to the present invention. When the end42 (not shown) of the original rod24 (seeFIG. 4C) extends past thelast pedicle screw26 to allow therod extension22 to fit over this extendingend42 without contacting the last pedicle screw26 (not shown, located along theoriginal rod24, distal to the interface of therod extension22 and the original rod24), theclamp70 may be used in place of thepedicle screw26/set screw40 combination to attach therod extension22 to theoriginal rod24. Theclamp70 may be any biocompatible clamp suitable for applying pressure around a rod. Theclamp70 may include ascrew72 or other means for tightening theclamp70 on thearms30a,30bof therod extension22, thereby frictionally attaching therod extension22 to theoriginal rod24.
Referring toFIG. 7, there is shown an alternate embodiment of the present invention wherein asize adjusting rod80 may extend an original rod90 (seeFIG. 8) into arod extension body88 having alarger diameter88athan that of theoriginal rod90 according to the present invention.Dotted lines82 may show where a new rod90 (seeFIG. 8) may be inserted. Thesize adjusting rod80 may includearms82a,82bseparated by aslot84, and asleeve portion86, similar to therod extension22 described above. In one embodiment of the present invention, thesize adjusting rod80 may be an original implant in a patient where a future implant may be needed. For example, thesize adjusting rod80 may be implanted in a thoracic spine reconstruction. Theend84aand the slots84 (only one shown) of thesize adjusting rod80 may be filled with a spacer (not shown). The spacer may be any biocompatible spacer to prevent tissue growth inside thesize adjusting rod80. If the patient later needs cervical spine fixation, the spacer can be removed and thenew rod90 may be inserted and clamped as shown inFIG. 9. This size adjusting configuration, usingsize adjusting rod80, may also be used acutely, for example, when doing thoracic and cervical spine fixation at the same time.
Referring now toFIG. 9, there is shown a perspective view of arod extension100 according to another exemplary embodiment of the present invention. Therod extension100 is similar to therod extension22 described above in that therod extension100 has anarm102 that fits over theoriginal rod24. Similar to therod extension22,rod extension100 may provide inline extension of theoriginal rod24. Alternatively, therod extension100 may provide an offset (not shown) between therod extension body104 and theoriginal rod24. Therod extension100 may include a pedicle screwfitting portion106 which may fit over thelast pedicle screw26 of theoriginal rod24. However, the pedicle screwfitting portion106 may be present along any portion of thearm102. As shown inFIG. 9, the pedicle screwfitting portion106 may be centrally located along thearm102. Where there may be sufficient amount oforiginal rod24 extending beyond the last pedicle screw26 (theend portion42 of the original rod24) so that thearm102 does not contact thelast pedicle screw26 of theoriginal rod24, the pedicle screwfitting portion106 may not be necessary, as theentire arm102 may fit onto theend portion42, as shown inFIG. 10. Unlike conventional inline domino extensions, which may require a significant length of theend42 extending beyond thelast pedicle screw26 for which to attach the domino, the present invention may be used to extendoriginal rods24 which do not have long ends42 extending beyond thelast pedicle screw26.
Referring toFIG. 11, there is shown a plan view of therod extension100 according to the present invention. The pedicle screwfitting portion106 may include anopening120 allowing access to the set screw40 (not shown) of thepedicle screw26. Typically, fitting thearm102 of therod extension100 of the present invention over the original rod25 may not require loosening or adjustment of theset screw40. However, should adjustment be necessary, theopening120 may provide access thereto.
Referring toFIG. 12, there is shown an end view of therod extension100 according to the present invention. Thearm102 of therod extension100 may have aminimum diameter102athat is smaller than thediameter24aof the original rod24 (seeFIG. 4C). Thearm102 may form a semi-circle shape that is more than180 degrees (more than half a circle). With this configuration, theoriginal rod24 may fit into thearm102 of therod extension100 by applying a force to open theends102b,102cof the arms to allow theoriginal rod24 to fit in place. Once installed, a similar, opposite force may be needed to remove theoriginal rod24 from thearm102. This configuration may help keep the two components of the new construct (therod extension100 and the original rod24) joined together.
Referring now toFIGS. 13A and 13B, there are shown perspective views of therod extension100 attached to theoriginal rod24. Referring specifically toFIG. 13A, aspace140 may be present between theend42 of theoriginal rod24 and theend108 of therod extension body104. Depending upon the amount of theoriginal rod24 that extends beyond thelast pedicle screw26, thisspace140 may be from zero to about 8 mm or longer. Typically, thisspace140 may be between about 1 mm to about 6 mm. Minimizing thespace140 may minimize the leverage placed on the linkage between the original rod and the rod extension.
Referring toFIGS. 14A through 14C there is shown, graphically, a method for extending theoriginal rod24 with therod extension100. InFIG. 14A, therod extension100 may be placed over theoriginal rod24 with the pedicle screwfitting portion106 fitting over thepedicle screw26. Aclamp150 may be opened and aligned next to thearm102 of therod extension100. InFIG. 14B, theclamp150 is placed around thearm102 andoriginal rod24 and aclamp screw152 may be aligned to be inserted into the clamp. InFIG. 14C, theclamp screw152 may be inserted into theclamp150 and tightened, thereby providing a frictional fit between thearm102 and theoriginal rod24. WhileFIGS. 14A through 14C show theclamp150 on thearm102 distal to the pedicle screwfitting portion106, theclamp150 may be placed, as an alternate to, or in addition to the configuration shown in the figures, on thearm102 proximate to the pedicle screw fitting portion106 (as shown byarrow154 inFIG. 14C), where distal and proximate refer to the pedicle screwfitting portion106 relative to therod extension body104.
Similar to therod extension22 described above, the diameter of the rod extension body104 (indicated as104ainFIG. 14C) may be any diameter suitable for the intended purpose, including diameters that are the same, smaller or larger than that of theoriginal rod24.
Referring toFIG. 15, there is shown amethod200 for extending a previously implanted spine reconstruction rod (e.g., original rod24) with a rod extension (e.g., rod extension22). Themethod200 may include astep210 of exposing only the end (e.g., end42) of the previously implanted spine reconstruction rod, including the last pedicle screw (e.g., last pedicle screw26). Unlike conventional methods, which may require exposure of the entire length of the previously implanted rod, the present invention may only require exposure of the end of the previously implanted rod adjacent to where the new construct (rod extension) is to be added.
Once the end of the previously implanted rod is exposed, themethod200 may include astep220 of positioning the rod extension in-line with the previously implanted spine reconstruction rod. According to one aspect of the present invention, the rod extension may be positioned with its end abutting the end of the previously implanted spine reconstruction rod. Unlike conventional methods, which may place the new rod along side of the original rod and then bend the new rod to be inline with the original rod, the present invention does not require such a bending which may weaken the spine reconstruction rod.
Finally, once the rod extension is positioned, themethod200 may include astep230 of securing the rod extension to the previously implanted spine reconstruction rod without the use of a separate domino. The securingstep230 may performed by, for example, a) clamping one arm from the rod extension to the original rod; b) clamping two arms from the rod extension to the original rod; or c) securing at least one arm from the rod extension to a set screw of the last pedicle screw of the original rod.
Both therod extension22 and therod extension100 may have arms (30,30a,30bor102, respectively) that are relatively thin. For example, the arms may be from about 0.1 to about 0.4 mm thick, typically about 0.2 mm thick. While not agreeing to any one theory, there are several reasons why the arms joining the rods may be made thin. For example, the ends of the rods (ends42 and108, for example) may be brought close together, as discussed above. This closeness may minimize the leverage placed on the linkage between the original rod and the rod extension. Additionally, even though the arms themselves are thin, when the rod extensions are connected to the original arms, the thickness at the junction is slightly larger than the rods themselves, as discussed above, thus strengthening the region where the rods (the original and the extension) are joined. Finally, with respect torod extension22, the original rod may slide into a sleeve of the rod extension. This configuration may give circumferential linkage further strengthening to the junction between the two rods.
It should be understood, of course, that the foregoing relates to exemplary embodiments of the invention and that modifications may be made without departing from the spirit and scope of the invention as set forth in the following claims.